Prescribing Information

For Patients

Recombivax [hepatitis b vaccine (recombinant)] is a vaccine used to help prevent the disease Hepatitis B. It is a viral vaccine. Common side effects include pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness.

The dose of Recombivax is a vaccination regimen of 3 doses of vaccine given according to the following schedule: First dose: at elected date; Second dose: 1 month later; Third dose: 6 months after the first dose. Adolescents 11 to 15 years may follow a 2 dose regimen. Recombivax may interact with other recent vaccines, steroid medicines, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications you use. During pregnancy, Recombivax should be used only when prescribed. It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Recombivax [hepatitis b vaccine (recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

SIDE EFFECTS: Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

In healthy infants and children (up to 10 years of age),
the most frequently reported systemic adverse reactions ( > 1% injections), in
decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness,
diminished appetite, and rhinitis. In healthy adults, injection site reactions
and systemic adverse reactions were reported following 17% and 15% of the
injections, respectively.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
vaccine cannot be directly compared to rates in the clinical trials of another vaccine
and may not reflect the rates observed in practice.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5
mcg, were administered to 147 healthy infants and children (up to 10 years of
age) who were monitored for 5 days after each dose. Injection site reactions
and systemic adverse reactions were reported following 0.2% and 10.4% of the
injections, respectively. The most frequently reported systemic adverse
reactions ( > 1% injections), in decreasing order of frequency, were
irritability, fever ( ≥ 101°F oral equivalent), diarrhea,
fatigue/weakness, diminished appetite, and rhinitis.

In a study that compared the three-dose regimen (5 mcg)
with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall
frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10
mcg, were administered to 1252 healthy adults who were monitored for 5 days
after each dose. Injection site reactions and systemic adverse reactions were
reported following 17% and 15% of the injections, respectively. The following
adverse reactions were reported:

Blood And Lymphatic Disorders

Psychiatric Disorders

Ear And Labyrinth Disorders

Renal And Urinary Disorders

Cardiac Disorders

Post-Marketing Experience

The following additional adverse reactions have been
reported with use of the marketed vaccine. Because these reactions are reported
voluntarily from a population of uncertain size, it is not possible to reliably
estimate their frequency or establish a causal relationship to a vaccine
exposure.